510(k) K001052

MED-TEC (MEDICAL INTELLIGENCE) BODYFIX SYSTEM, MODEL MT-BFX by Med-Tec,Inc. — Product Code IYE

K001052 is an FDA 510(k) premarket notification submitted by Med-Tec,Inc. for the device "MED-TEC (MEDICAL INTELLIGENCE) BODYFIX SYSTEM, MODEL MT-BFX". The FDA issued a decision of Substantially Equivalent on August 30, 2000. The device falls under product code IYE (Accelerator, Linear, Medical), a Class II device regulated under 21 CFR 892.5050. Med-Tec,Inc. has at least 7 other 510(k) clearances on record.